Dryness Difference Between Before and After Phacoemulsification

July 18, 2024 updated by: Mohamed Samir, Sohag University

Evaluation Of Dry Eye After Uneventful Phacoemulsification

The aim of this study is to compare tear film and tear film secretion before and after phacoemulsificaton cataract surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The tear film is a thin fluid layer overlies the ocular surface and provides the interface between the ocular surface and the external environment.

  • It consists of three layers (lipid, aqueous and mucous) which act together to protect the corneal and conjunctival tissues and keeping them healthy.
  • The superficial lipid layer is secreted by meibomian glands and functions as a smooth optical surface, reduces surface tension of the tear film, prevents anterior migration of aqueous tears on to the lid margin and retards evaporation .
  • The Mucous layer is secreted by the goblet cells of the conjunctiva. It contains mucins that is very essential for lubrication, and wetting.
  • The aqueous tear layer is mainly produced by the main lacrimal glands with small amounts produced by the goblet cells in the conjunctiva and accessory lacrimal glands and This layer acts by providing oxygen and nutrients to the avascular corneal tissue, washing away tissue debris, toxins, and foreign bodies, and also protecting the ocular surface from microbes.
  • Cataract is the common cause of vision loss in the developing countries, also its rate of incidence increases with aging. So it is essential for those patients to undergo cataract surgeries to improve their vision and protect them from blindness.
  • Phacoemulsification is the most recent cataract surgery at which a small incision is done then the ultrasonic power is used to fragment and emulsify the cataract. It was first introduced by Dr. Charlies Kelman and now Most surgeons prefer phacoemulsification surgery because of less postoperative astigmatism, faster stabilization of vision and refraction, and less postoperative inflammation
  • Some surgical interventions related to the anterior segment may also cause dry eye and aggravate the symptoms of pre-existing dry eye, like PRK, LASIK, and cataract surgery by extra capsular cataract extraction, because a large incision is created in the eye during the procedure that sometimes damages the cornea and also can occur with phacoemulsification with a smaller incision.
  • There are many tests that are used to estimate the degree of dryness and its severity which measure tear stability, tear production, and the presence of ocular surface disorders like Schirmer's test , which is used to evaluate tear production and the severity of dry eye by estimating the amount of special filter paper wetting that is put in the lower fornix for 5 minutes, and the Tears Break Up Time test, which is important to evaluate the tear film stability and evaporation.
  • In this study we aim to evaluate dry eye affection after phacoemulsification whether it is worsen or not and the degree of increased dryness especially that dry eye syndrome is very common in our community and how phacoemulsification is now a frequent and preferred operation.

After taking a good detailed history The following assessments were performed in each patient before surgery and at the 2-week and 1-, 3-, and 6-month follow-up visits by the following tests:

  1. Non-invasive tear film break up time (TBUT), a parameter of tear film stability.
  2. Non-invasive tear meniscus height.
  3. Evaluation of Meibomian glands function.
  4. Lipid layer thickness.
  5. Eyelid margin.
  6. Analysis of conjunctival hyperemia.

  7. Cornea sodium fluorescein staining.

    • Schirmer I test, a measure of basic and reflex tear secretion, was performed without anesthesia. This test was performed by placing Schirmer strips over the lower lid margin; the strip wetting was measured and recorded in millimeters.
    • Dry eye symptoms patients were classified as having dry eye disease if they reported experiencing one or more of the primary symptoms (soreness, scratchiness, dryness, grittiness, burning) often or constantly, the TBUT value was less than 10 seconds, and in Schirmer test I there is less than 10 mm wetting of filter paper for a period of 6 months or more after surgery.
    • Visual acuity before and after surgery.
    • Anterior segment examination by slit lamp.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag university hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

this study included 100 cataract patients, with age above 45 years old who underwent uncomplicated phacoemulsification surgery

Description

Inclusion criteria:

  • Cataract patients.
  • Cases within age > 45 years old.

Exclusion criteria:

  • Patients with ocular surface diseases and eyelid abnormality.
  • Patients receive ocular or systemic medications, that interfere with tear film production and stability (e.g. topical eye drops that contain preservatives, antihistaminic drugs, anticholinergic drugs, contraceptive pills).
  • Patients with systemic diseases like diabetes, HTN, rheumatoid arthritis. - Patients underwent previous ocular surgeries that interfere with tears instability or production (e.g. refractive surgery, keratoplasty, eyelid surgeries, pterygium excision).
  • Patients with a history of trauma, chemical burn, overusing contact lens (due to damaging the conjunctiva and the goblet cells, also corneal sensitivity reduction).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using tear film break up time in seconds.
Time Frame: Before the operation and 2-week and 1, 3, and 6 month after the operation
Analysis of dryness before and after uncomplicated phacoemulsification using tear film break up time in seconds.
Before the operation and 2-week and 1, 3, and 6 month after the operation
Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using tear meniscus height in millimeters.
Time Frame: Before the operation and 2-week and 1, 3, and 6 month after the operation
Analysis of dryness before and after uncomplicated phacoemulsification using tear meniscus height in millimeters.
Before the operation and 2-week and 1, 3, and 6 month after the operation
Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using Lipid layer thickness in nanometers.
Time Frame: Before the operation and 2-week and 1, 3, and 6 month after the operation
Analysis of dryness before and after uncomplicated phacoemulsification using Lipid layer thickness in nanometers..
Before the operation and 2-week and 1, 3, and 6 month after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hatem Gamal eldeen, Professor, Sohag University
  • Study Chair: Mahmoud Mohamed farouk, Professor, Sohag University
  • Study Chair: Hany Mahmoud, Lecturer, Sohag University
  • Principal Investigator: Mohamed samir zayed, resident, Tahta ophthalmology hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dryness post phaco

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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